Running a MedTech startup means managing four stakeholder groups at once — investors, your Notified Body, clinical partners, and payers — each with different information needs, legal constraints, and risk tolerances. MDR Article 7 puts a hard legal limit on what you can say about your device to any of them before you have the evidence to back it up.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • MedTech founders juggle at least four external stakeholder groups with conflicting incentives: investors want upside, Notified Bodies want conformity, clinical partners want scientific rigour, payers want outcomes.
  • MDR Article 7 forbids any text, label, or statement that attributes functions or properties to a device it does not have, creates a false impression about the benefit-risk profile, or fails to inform users of likely risks.
  • Article 7 applies to pitch decks, LinkedIn posts, press releases, and investor updates — not just product labelling. Regulators have fined companies for investor communications.
  • Your Notified Body is not a stakeholder you "manage" in the marketing sense — they are an accredited conformity assessment body whose legal relationship with you is defined by contract and by MDR Annex VII.
  • Clinical partner agreements must be written before data is collected. EN ISO 14155:2020+A11:2024 and MDR Articles 62–82 set the ground rules for any investigation generating data for your CER.
  • A quarterly stakeholder cadence — monthly for investors, milestone-based for the Notified Body, study-phase for clinical partners, yearly for payers — is enough for most early-stage companies.

Why this matters (Hook)

A founder I coached last year raised a Series A on the back of a deck that said her SaMD "detects early-stage disease with 94% accuracy". The number was real — from a retrospective study on 312 patients. The problem: the product was not yet CE-marked, the claim had never been part of a signed-off intended purpose, and the press release that followed was picked up by a trade publication. Three weeks later, her Notified Body sent an email asking for the "clinical evidence supporting the marketing claims". That email cost her four months of CER rework, a delay to Stage 2 audit, and an investor bridge round.

This was not bad luck. It was a stakeholder management failure. She said one thing to investors that she had not earned the right to say to anyone, and a regulator noticed. MDR Article 7 does not care who the audience is. A claim is a claim.

Managing MedTech stakeholders well is not about polish or PR. It is about understanding that the four groups you talk to every week have different legal standings, different information rights, and different consequences when you get it wrong.

What MDR actually says (Surface)

The single most important provision for stakeholder communication is Article 7 (Claims) of Regulation (EU) 2017/745. It states that in the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

  • ascribing functions and properties to the device which the device does not have;
  • creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
  • failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
  • suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

In plain language: you cannot claim things your device does not do, and you cannot claim things your device might do but that your technical documentation has not yet proven. Competent authorities have repeatedly clarified — and enforcement practice confirms — that Article 7 applies to all commercial communications, including investor decks, trade press, conference posters and LinkedIn.

Article 10 puts the manufacturer obligations on you. Whatever you say, whoever you partner with, the manufacturer is accountable. You cannot delegate this. Article 10(1) requires you to ensure devices are designed and manufactured in accordance with MDR requirements; Article 10(9) requires a QMS covering clinical evaluation, risk management, PMS and more.

Article 61 and Annex XIV Part A govern clinical evidence, which in turn governs what you can claim. A claim without traceable clinical evidence in the CER is a finding waiting to happen.

Articles 62–82 and Annex XV govern clinical investigations — the rules that apply the moment a clinical partner starts collecting data on your device under your sponsorship. These are complemented by EN ISO 14155:2020+A11:2024 on GCP for medical device investigations.

A worked example (Test)

Take a Class IIa digital therapeutic for post-stroke rehabilitation. The startup has a pilot with a university hospital (80 patients, six months), a lead investor pushing for a splashy launch, a Notified Body in Stage 1, and early conversations with a German statutory health insurer about DiGA reimbursement.

Here is what each stakeholder actually wants to hear:

Investor update (monthly): burn rate, runway, regulatory milestones (Stage 1 complete, Stage 2 scheduled for October), clinical data collection progress (N=42 of 80), pipeline of payer conversations. No claims about effectiveness unless they are already in the signed intended purpose. If the pilot shows a 22% improvement in Fugl-Meyer scores, the update can say "preliminary pilot data is trending positively and will be included in the CER" — it cannot say "our device improves motor function by 22%".

Notified Body (milestone-based): answers to nonconformities, planned CAPA closures, change notifications (Article 120), timeline adherence. Communication is factual, document-referenced, and slow on purpose. Your NB is not your advisor. They are your auditor. They cannot tell you how to pass the audit; they can only tell you whether you passed.

Clinical partner (weekly during data collection): recruitment status, protocol deviations, adverse event reporting (per EN ISO 14155), data quality. The written clinical investigation agreement signed before patient 1 must cover sponsorship (usually the manufacturer), data ownership, publication rights, indemnification, and handling of incidental findings.

Payer (quarterly): real-world usage data, comparative outcomes vs standard of care, cost-effectiveness modelling. Payers want health-economic evidence — which is different from, and complementary to, the clinical evidence your NB wants to see.

The Article 7 trap hides in the overlap. The same deck shown to investors often ends up in the payer conversation. The same case study discussed with the clinical partner ends up in a LinkedIn post. The moment a claim is in writing anywhere visible, it is subject to Article 7.

The Subtract to Ship playbook (Ship)

1. One claims register, one source of truth. Maintain a single document — living — listing every claim your company has ever made about the device, where it was made, and the evidence in your technical documentation that supports it. Every new pitch deck, press release or investor update references this register. If a claim is not in the register, it does not go out.

2. Match the cadence to the legal standing. Investors monthly (contractual). Notified Body milestone-based (contractual, via formal change notifications and audit findings responses). Clinical partners weekly during data collection (per Clinical Investigation Plan). Payers quarterly (relationship building, no contractual urgency at early stage).

3. Separate regulated from unregulated content. Your intended purpose and approved claims are regulated. Your company story, team, mission, and market view are not. Keep these in different slide decks. When they blend — "our AI radically improves outcomes" — you are one screenshot away from an Article 7 complaint.

4. Written clinical partner agreements before data. Before a single patient is enrolled in any study feeding your CER, you need: sponsor identification (almost always you, the manufacturer), scope of data collected, data ownership, publication plan, serious adverse event reporting chain, insurance coverage per Article 69, and investigator obligations. EN ISO 14155:2020+A11:2024 gives the template.

5. Notified Body communication discipline. Every email to your NB is a document your auditor may read. Treat each message as a record. Use a single point of contact on your side (typically the PRRC or the regulatory lead). Never ask your NB for advice on how to interpret a GSPR — they cannot answer and it creates a conflict.

6. Payer conversations are evidence-building, not deal-making. Early-stage payer conversations are about learning what evidence they need (cost-effectiveness, comparator, patient-reported outcomes) so you can build your PMCF plan around it. Do not promise coverage. Do not promise pricing.

7. Kill the puffery in investor updates. "Breakthrough", "game-changer", "world-first" are Article 7 minefields when attached to a device. Use factual milestones instead: "CE mark targeted Q3 2027", "CER draft complete", "first 50 patients enrolled".

Reality Check

  1. Do you have a single claims register listing every public statement about your device and the evidence supporting each one?
  2. When was the last time your investor update or pitch deck was reviewed by someone competent in MDR Article 7?
  3. Does your Notified Body communication go through a single, trained point of contact, or does every founder reply directly?
  4. Do you have signed clinical investigation agreements (not MOUs) with every clinical partner generating data for your CER?
  5. Can your clinical partner publish results without your consent? (If yes — is that what you want?)
  6. Does your payer conversation deck contain claims not yet in your signed intended purpose?
  7. If a screenshot of your LinkedIn feed were handed to a competent authority tomorrow, would any post trigger an Article 7 inquiry?
  8. Do you know the difference between what your NB wants to see (conformity evidence) and what your payer wants to see (economic and outcomes evidence)?

Frequently Asked Questions

Can I share our Notified Body's name in investor materials before CE marking? You can confirm you have a contract with a specific NB, but you cannot imply endorsement or imminent approval. Your NB has not approved anything until the certificate is issued. Any language suggesting otherwise risks Article 7 and contract breach.

Does Article 7 apply to a private investor deck? Yes. Competent authorities have taken the view that any communication that may reach users, patients or the market falls under Article 7. Investor materials circulate widely, end up on the public web, and are quoted in press. Treat them as public.

Who signs the clinical investigation agreement — the manufacturer or the CEO? The legal entity (the manufacturer) signs, represented by an authorised signatory. The sponsor obligations under MDR Articles 71–77 rest with the manufacturer, not with a CRO or a hospital.

Can my clinical partner use the data for their own publications? Only if the agreement allows it, and only with your review rights. Publication timing matters — a premature paper can create Article 7 exposure if the claims diverge from your eventual intended purpose.

How often should I meet my Notified Body outside of audits? Rarely. Most NBs charge for time, and excessive informal contact is poor signal. Communicate through formal channels — change notifications, audit responses, scheduled reviews.

Is talking to payers before CE mark worth the effort? Yes, for evidence planning. Early payer input shapes your PMCF plan so that post-market data serves both MDR obligations and reimbursement submissions. No, for pricing conversations — you have no product to sell yet.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Article 7 (Claims), Article 10 (General obligations of manufacturers), Article 61 (Clinical evaluation), Articles 62–82 (Clinical investigations), Annex XV.
  2. EN ISO 14155:2020+A11:2024 — Clinical investigation of medical devices for human subjects — Good clinical practice.
  3. MDCG 2020-5 (April 2020) — Clinical evaluation equivalence.